Web-Based Conversational Assistant After Total Knee Arthroplasty (CARE-TKA)
23. juli 2026 oppdatert av: Wojciech Sroga
Evaluation of a Web-Based Conversational Postoperative Assistant on Patient Satisfaction and Exercise Adherence After Total Knee Arthroplasty: Protocol of a Pragmatic Randomized Pilot Study With 6-Week Follow-up
Total knee arthroplasty (TKA) is one of the most frequently performed elective orthopaedic procedures.
Following hospital discharge, patients must manage pain, wound care and home rehabilitation with limited professional support.
This pragmatic randomised pilot trial will evaluate whether a web-based conversational postoperative assistant, used in addition to standard care, improves patient satisfaction and exercise adherence during the first 6 weeks after TKA.
Forty to sixty patients undergoing primary elective TKA will be randomised 1:1 to standard care with or without access to the conversational assistant.
The primary outcome is overall patient satisfaction at 6 weeks.
Secondary outcomes include pain intensity, exercise adherence, unplanned healthcare contacts and postoperative complications.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This single-centre pragmatic randomized pilot trial will evaluate the feasibility and preliminary effectiveness of a web-based conversational postoperative assistant following primary total knee arthroplasty (TKA). Participants will be randomized in a 1:1 ratio to receive either standard postoperative care alone or standard care plus access to the conversational assistant for 6 weeks after surgery.
The assistant provides evidence-based postoperative education, recovery guidance, answers to common patient questions, and safety-oriented recommendations. The primary outcome is overall patient satisfaction at 6 weeks. Secondary outcomes include pain intensity, exercise adherence, unplanned healthcare contacts, and postoperative complications. The study is designed to generate preliminary evidence to support the development of a larger definitive randomized controlled trial.
Studietype
Intervensjonell
Registrering (Antatt)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Alicante
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Alcoy, Alicante, Spania, 03803
- Hospital Universitario Virgen de los Lirios
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Ta kontakt med:
- Wojciech Sroga, MD
- Telefonnummer: +34 648617730
- E-post: wstrauma@gmail.com
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Ta kontakt med:
- E-post: wstrauma@gmail.com
-
Hovedetterforsker:
- Wojciech Sroga, MD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Age ≥18 years.
- Primary, unilateral, elective total knee arthroplasty (TKA).
- Discharged to home following surgery.
- Ability to use a smartphone or tablet with internet access (patient or caregiver).
- Written informed consent provided.
Exclusion Criteria:
- Revision or bilateral simultaneous TKA.
- Major postoperative complication precluding home discharge (e.g., admission to intensive care, unplanned return to theatre, or haemodynamic instability).
- Severe cognitive impairment precluding informed consent or device use.
- No access to an internet-enabled device.
- Inability or refusal to complete follow-up.
- Participation in another interventional study at enrolment.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Intervention
Participants receive standard postoperative care plus access to a web-based conversational postoperative assistant for 6 weeks after primary total knee arthroplasty.
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Participants assigned to the intervention group receive access to a web-based conversational assistant for 6 weeks after primary total knee arthroplasty.
The assistant provides evidence-based postoperative education, recovery guidance, answers to common patient questions, and safety-oriented recommendations.
It is available on demand and complements, but does not replace, standard postoperative care.
|
|
Ingen inngripen: Control
Participants receive standard postoperative care without access to the web-based conversational postoperative assistant.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Overall Patient Satisfaction
Tidsramme: 6 weeks after total knee arthroplasty
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Overall patient satisfaction measured using an 11-point Numeric Rating Scale (NRS), where 0 indicates not satisfied at all and 10 indicates completely satisfied.
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6 weeks after total knee arthroplasty
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pain Intensity
Tidsramme: 2 weeks and 6 weeks after total knee arthroplasty
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Pain intensity measured using an 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
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2 weeks and 6 weeks after total knee arthroplasty
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Exercise Adherence
Tidsramme: During the first 6 weeks after total knee arthroplasty
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Exercise adherence assessed as the percentage of prescribed home exercise sessions completed, based on the participant's exercise diary.
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During the first 6 weeks after total knee arthroplasty
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Unplanned Healthcare Contacts
Tidsramme: During the first 6 weeks after total knee arthroplasty
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Number of unplanned healthcare contacts related to the operated knee, including primary care visits, emergency department visits, outpatient consultations, and hospital readmissions.
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During the first 6 weeks after total knee arthroplasty
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Postoperative Complications
Tidsramme: During the first 6 weeks after total knee arthroplasty
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Occurrence of postoperative complications related to the surgical procedure.
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During the first 6 weeks after total knee arthroplasty
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. oktober 2026
Primær fullføring (Antatt)
1. mars 2027
Studiet fullført (Antatt)
1. mars 2027
Datoer for studieregistrering
Først innsendt
23. juli 2026
Først innsendt som oppfylte QC-kriteriene
23. juli 2026
Først lagt ut (Faktiske)
28. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HGUVL-TKA-001
Plan for individuelle deltakerdata (IPD)
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